SLEEP HP- arsenicum album, avena sativa, coffea cruda, kali carbonicum, magnesia carbonica, nux vomica, passiflora incarnata, sepia, valeriana officinalis liquid 
Grato Holdings, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Drug Facts:

ACTIVE INGREDIENTS:

(in each drop): 11.11% of Arsenicum Album 30X, Avena Sativa 30X, Coffea Cruda 30X, Kali Carbonicum 30X, Magnesia Carbonica 30X, Nux Vomica 30X, Passiflora Incarnata 30X, Sepia 30X, Valeriana Officinalis 30X.

INDICATIONS:

May temporary relieve symptoms due to fatigue and restlessness from inability to sleep.**

**Claims based on traditional homeopathic practice. Not FDA evaluated.

WARNINGS:

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

INDICATIONS:

May temporary relieve symptoms due to fatigue and restlessness from inability to sleep.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENTS:

Demineralized water, 20% Ethanol.

QUESTIONS:

Dist. by Grato Holdings, Inc.

201 Apple Blvd.

Woodbine, IA 51579 800-869-8078

PACKAGE LABEL DISPLAY:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

SLEEP HP

1 fl. oz. (30 ml)

Sleep HP

SLEEP HP 
arsenicum album, avena sativa, coffea cruda, kali carbonicum, magnesia carbonica, nux vomica, passiflora incarnata, sepia, valeriana officinalis liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70163-0002
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE30 [hp_X]  in 1 mL
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP30 [hp_X]  in 1 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN30 [hp_X]  in 1 mL
POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE30   in 1 mL
MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D) MAGNESIUM CARBONATE30 [hp_X]  in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED30 [hp_X]  in 1 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP30 [hp_X]  in 1 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE30 [hp_X]  in 1 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN30 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70163-0002-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product11/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic11/30/2020
Labeler - Grato Holdings, Inc. (078452966)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(70163-0002) , api manufacture(70163-0002) , label(70163-0002) , pack(70163-0002)

Revised: 11/2020
Document Id: f934b0f4-d90e-42ff-9226-839dd03bcb38
Set id: 90e8553a-cfa9-4bb1-a398-3242a4e7456b
Version: 1
Effective Time: 20201130
 
Grato Holdings, Inc.